Your Clinical Evaluation is the cornerstone of your technical documentation. It provides the evidence that your medical device meets the EU MDR’s General Safety and Performance Requirements (GSPRs) and is fully compliant with the regulation.
We’re announcing the launch of a new service designed to help you with your CER, CEP, and SOTA documentation – ensuring that your documents meet Notified Body expectations and accelerating your route to market with confidence.
Is your Clinical Evaluation truly submission ready?
We understand that crafting a Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), and State-of-the-Art (SOTA) Report report that satisfies both the scientific rigour and the stringent expectations of regulators is no simple task. That’s where a pre-submission check adds value, offering an independent, expert assessment to identify gaps, strengthen your evidence, and ensure readiness before submission to notified bodies. The outcome: fewer review cycles, reduced review costs and a smoother, faster route to market.
What do you get with the Mantra Systems pre-submission check?
A Clinical Evaluation review is not a generic checklist; it is a tailored service designed to address the specific needs of your device and its evidence base. Our review covers:
- Template and structure check: Ensuring your Clinical Evaluation documents follow an MDR-ready format
- Content assessment: Evaluating everything from your literature review methodology, clinical data analysis, and risk/benefit justification
- Gap identification: Highlighting missing or insufficient information that could weaken compliance
- Actionable recommendations: Clear, practical steps for strengthening your Clinical Evaluation before submission.
The result is a strengthened, defensible Clinical Evaluation that not only meets compliance requirements but also tells a clear and compelling story about your device’s safety and performance.
Who Performs the Review?
Effective Clinical Evaluation Reviews require professionals who understand both regulatory expectations and clinical research methodology. That is why our reviews are completed by experienced medical writers from scientific and clinical backgrounds with in-depth knowledge of the EU MDR, MEDDEV 2.7/1 Rev. 4, MDCG guidance, and ISO standards. Each reviewer combines scientific expertise with practical insight from working directly with Notified Bodies, enabling them to anticipate and address the kinds of questions and objections that can arise during review.
This blend of clinical and regulatory experience ensures that your CER, CEP, and SOTA documentation are not only technically accurate but also strategically presented to withstand the most rigorous evaluation.
Submission Ready? Get One Last Check First.
In today’s regulatory environment, a robust, well-prepared Clinical Evaluation is critical. Our pre-submission check helps you ensure that your documentation is accurate, compliant, and ready for the high standards of notified body review.
With this level of preparation, you don’t just submit a Clincal Evaluation; you present clear, defensible evidence that builds trust, accelerates approval, and positions your device for success in the EU market.
